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Trial registered on ANZCTR
Registration number
ACTRN12622001330730
Ethics application status
Approved
Date submitted
14/09/2022
Date registered
14/10/2022
Date last updated
11/04/2024
Date data sharing statement initially provided
14/10/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
The role of nebulized sodium nitrite and argon on blood pressure and brain blood flow control
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Scientific title
Elucidating the effects of nebulized sodium nitrite and argon on blood pressure and cerebrovascular haemodynamics in healthy adults and hypertensive patients
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Secondary ID [1]
307627
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Nil
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Universal Trial Number (UTN)
U1111-1277-7574
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
327111
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Condition category
Condition code
Cardiovascular
324258
324258
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0
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Hypertension
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Stroke
324942
324942
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0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The participants will undergo 5 min nebulized sodium nitrite (45 mg & 90 mg) with a nebuliser mask and 2 hour argon gas inhalation (79% argon and 21% oxygen) with a mouthpiece in a single-blinded manner with a 7 day washout period. Research staff will be present to monitor adherence to the intervention. These doses have been shown to be safe in healthy cohorts as well as clinical groups.
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Intervention code [1]
324427
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Treatment: Drugs
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Comparator / control treatment
This is a placebo-controlled cross-over design. For the nebulized sodium nitrite arm of the study, a saline placebo (normal saline) will be used. For the argon-inhalation arm of the study, room air will be used as placebo.
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Control group
Placebo
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Outcomes
Primary outcome [1]
332539
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Resting brachial blood pressure using a automated digital sphygmomanometer (BP+)
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Assessment method [1]
332539
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Timepoint [1]
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For the nebulized sodium nitrite arm, brachial blood pressure will be assessed prior to intervention (i.e., baseline) and upon completion of the intervention (10 min - primary endpoint), and at hour 1 and 2 post completion of intervention.
For the argon gas inhalation arm, brachial blood pressure will be assessed prior to intervention (i.e., baseline) and at hour 1 and 2 during the intervention, with primary endpoint being hour 2.
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Primary outcome [2]
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Global cerebral blood flow will be determined by measuring internal carotid artery and vertebral artery blood flows using duplex Doppler ultrasound
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Assessment method [2]
332540
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Timepoint [2]
332540
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For the nebulized sodium nitrite arm, global cerebral blood flow will be assessed prior to intervention (i.e., baseline) and upon completion of the intervention (10 min - primary endpoint), and at hour 1 and 2 post completion of intervention.
For the argon gas inhalation arm, global cerebral blood flow will be assessed prior to intervention (i.e., baseline) and at hour 1 and 2 during the intervention, with primary endpoint being hour 2.
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Secondary outcome [1]
413853
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Middle cerebral artery velocity, assessed using transcranial Doppler ultrasound
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Assessment method [1]
413853
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Timepoint [1]
413853
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For the nebulized sodium nitrite arm, middle cerebral artery velocity will be assessed prior to intervention (i.e., baseline) and upon completion of the intervention (10 min), and at hour 1 and 2 post completion of intervention.
For the argon gas inhalation arm, middle cerebral artery velocity will be assessed prior to intervention (i.e., baseline) and at hour 1 and 2 during the intervention.
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Secondary outcome [2]
413854
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Pulmonary ventilation assessing using heated pneumotachography
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Assessment method [2]
413854
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Timepoint [2]
413854
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For the nebulized sodium nitrite arm, pulmonary ventilation will be assessed prior to intervention (i.e., baseline) and upon completion of the intervention (10 min), and at hour 1 and 2 post completion of intervention.
For the argon gas inhalation arm, pulmonary ventilation will be assessed prior to intervention (i.e., baseline) and at hour 1 and 2 during the intervention.
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Eligibility
Key inclusion criteria
Patients with essential hypertension (At least Stage 2 hypertension; untreated office systolic blood pressure (SBP) greater than or equal to 140 mmHg or diastolic blood pressure (DBP_ greater than or equal to 90 mmHg);
Patients with chronic atrial fibrillation, as established on ECG or Holter monitoring
Normotensive controls (office SBP less than or equal to 120 mmHg and DBP less than or equal to 80 mmHg);
Aged over 18 years;
Body mass index less than 35 kg/m2.
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Hemodynamically significant valvular heart disease (excluding atrial fibrillation e.g., stenosis, mechanical valve replacement)
Severe left ventricular systolic dysfunction
Recent acute coronary syndrome (<12 months) (e.g., myocardiac infarction, angioplasty, unstable angina)
Previous coronary artery bypass surgery
Secondary causes of hypertension (e.g., phaeochromocytoma)
Recent stroke/transient ischaemic attack (<12 months)
Current smoker
Body mass index <18 kg/m2.
Current pregnancy
Current user of recreational drugs
Current abuser of alcohol
Inability to fully or appropriately provide consent (e.g., language issue, reading capability)
Underlying medical conditions, which in the opinion of the Investigator place the participant at unacceptably high risk for participating in the study.
Chronic and systemic illness including:
Severe respiratory disease (e.g., chronic obstructive pulmonary disease);
Severe, uncontrolled type II diabetes;
Current treatment for cancer or complete remission <5 years
Connective tissue or inflammatory disease
Neurological / psychiatric disease (e.g., peripheral neuropathy, dementia, Parkisnon’s, epilepsy)
Infection or pyrexial illness
Uncontrolled thyroid disorders
Renal impairment (e.g., glomerulus filtration rate less than 60)
Liver disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed by a statistician.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/11/2022
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Actual
9/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
80
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Accrual to date
18
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Final
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Recruitment outside Australia
Country [1]
25009
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New Zealand
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State/province [1]
25009
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Funding & Sponsors
Funding source category [1]
311892
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Government body
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Name [1]
311892
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New Zealand Health Research Council
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Address [1]
311892
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Level 3/110 Stanley Street, Grafton, Auckland 1010
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Country [1]
311892
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New Zealand
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Funding source category [2]
316285
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Charities/Societies/Foundations
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Name [2]
316285
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Maurice Phyllis & Paykel Trust
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Address [2]
316285
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Country [2]
316285
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Auckland CBD, Auckland 1010
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Country
New Zealand
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Secondary sponsor category [1]
313774
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None
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Name [1]
313774
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Address [1]
313774
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Country [1]
313774
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
311327
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
311327
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
311327
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New Zealand
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Date submitted for ethics approval [1]
311327
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Approval date [1]
311327
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01/08/2022
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Ethics approval number [1]
311327
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Summary
Brief summary
Although stroke is among the most common causes of mortality and morbidity in New Zealand, there is limited options for improving stroke outcome at the ambulance-level. We and others have recently shown nitric oxide (NO) and argon can significantly reduce infarct volume in animal models of ischaemic stroke. Building on this, the goal of this research is to identify novel treatments to improve patient outcome following stroke. Using brachial blood pressure (BP), duplex and transcranial Doppler sonography to measure cerebral blood flow (CBF), we will determine the effects of nebulized sodium nitrite (an NO donor) and argon inhalation on blood pressure control and cerebral haemodyanmics in healthy individuals and hypertensive patients. We will test the hypotheses that 1) nebulized sodium nitrite will enhance blood pressure and cerebral blood flow control; and 2) argon gas inhalation will not significantly impact blood pressure or cerebral blood flow. Insights gained from this research will lay the foundation for future clinical trials to examine the use of argon to slow the progression of brain injury, which will significantly improve how acute stroke is treated and managed within New Zealand.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Mickey Fan
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Address
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Faculty of Health and Medical Sciences
The University of Auckland
85 Park Road
Grafton
Auckland 1023
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Country
120726
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New Zealand
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Phone
120726
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+64 212968936
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Fax
120726
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Email
120726
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[email protected]
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Contact person for public queries
Name
120727
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Dr Mickey Fan
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Address
120727
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Faculty of Health and Medical Sciences
The University of Auckland
85 Park Road
Grafton
Auckland 1023
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Country
120727
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New Zealand
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Phone
120727
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+64 212968936
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Fax
120727
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Email
120727
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[email protected]
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Contact person for scientific queries
Name
120728
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Dr Mickey Fan
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Address
120728
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Faculty of Health and Medical Sciences
The University of Auckland
85 Park Road
Grafton
Auckland 1023
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Country
120728
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New Zealand
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Phone
120728
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+64 212968936
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Fax
120728
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Email
120728
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
We currently do not have ethical approval for additional use of the IPD beyond the study
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
17119
Ethical approval
384417-(Uploaded-14-09-2022-07-49-03)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF